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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Brentuximab vedotin
Trade Name:  Adcetris
Date Designated:  09/07/2016
Orphan Designation:  Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/09/2017 
Approved Labeled Indication:  For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity End Date:    11/09/2024 
Exclusivity Protected Indication* :  For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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